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The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged > or = 18 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | IC51 |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Japanese Encephalitis purified inactivated vaccine (IC51) | Biological | IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability up to Day 56 | calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs) | Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Serious Adverse Events and Medically Attended Adverse Events | until Day 56 | |
| Changes in Laboratory Parameters | until Day 56 | |
| SCR and GMT of Subjects With Concomitant Vaccinations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Astrid Kaltenboeck, Ph.D. | Valneva Austria GmbH | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | IC51 | IC51 |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IC51 | IC51 |
| BG001 | Placebo | Placebo |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability up to Day 56 | calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs) | Safety Population | Posted | Number | percentage of participants with AEs | Day 56 |
|
|
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Safet population (N = 2650): All subjects who entered the study and received at least one vaccination. All analyses based on the safety population were carried out using the actual treatment received.
The safety population was used for all safety and tolerability analyses and for the analysis of demographic and background data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IC51 | IC51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Coronary Syndrome | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Clinical Research | Intercell AG | +43 1 206 20 | 1175 | kdubischar-kastner@intercell.com |
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| ID | Term |
|---|---|
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
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| Placebo | Biological | Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28 |
|
| until Day 56 |
| Pregnancy |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| administrative reasons |
|
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Rates of Serious Adverse Events and Medically Attended Adverse Events | Not Posted | until Day 56 | Participants |
| Secondary | Changes in Laboratory Parameters | Not Posted | until Day 56 | Participants |
| Secondary | SCR and GMT of Subjects With Concomitant Vaccinations | Not Posted | until Day 56 | Participants |
| 10 |
| 1,993 |
| 917 |
| 1,993 |
| EG001 | Placebo | Placebo | 6 | 657 | 292 | 657 |
| Proctalgia | Gastrointestinal disorders |
|
| Rectal Haemorrhage | Gastrointestinal disorders |
|
| Chest Pain | General disorders |
|
| Abscess Limb | Infections and infestations |
|
| Appendicitis | Infections and infestations |
|
| Face Injury | Injury, poisoning and procedural complications |
|
| Facial Bones Fracture | Injury, poisoning and procedural complications |
|
| Ulna Fracture | Injury, poisoning and procedural complications |
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| Calculus Urinary | Renal and urinary disorders |
|
| Adnexa Uteri Pain | Reproductive system and breast disorders |
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| Ovarian Cyst Ruptured | Reproductive system and breast disorders |
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| Ovarian Torsion | Reproductive system and breast disorders |
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| Dermatomyositis | Skin and subcutaneous tissue disorders |
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| Curculatory Collapse | Vascular disorders |
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| Fatigue | General disorders |
|
| Influenza Like Illness | General disorders |
|
| Pyrexia | General disorders |
|
| Nasopharyngitis | Infections and infestations |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
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| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |